Leykin 2008.
Methods | Randomized, double‐blind, active‐controlled study Medications administered 15 min before discontinuation of anesthesia |
|
Participants | Type of surgery: functional endoscopic sinus Propacetamol group Entered/completing: 25/25 Age (mean, SD): 32 ± 10 Sex (male, %): 72 Parecoxib group Entered/completing: 25/25 Age (mean, SD): 34 ± 12 Sex (male, %): 76 |
|
Interventions | Intervention: 2 g propacetamol over 15 min Control: 40 mg IV parecoxib |
|
Outcomes | Pain intensity (VAS) and derived SPID Opioid consumption (morphine) Patient satisfaction (categorical) |
|
Source of funding | Not reported | |
Were treatment groups comparable at baseline? | Yes: demographics; type of procedure. Intraoperative and postoperative hemodynamic variables also reported to be similar, but no data shown. | |
Details of preoperative pain | Participants with chronic pain requiring major analgesics, sedatives, or corticosteroids were excluded | |
Notes | Participants had only mild pain at baseline | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | Study drugs mixed by physician not involved in study. Double‐dummy technique employed. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Analyses on ITT population, but no mention of imputation method |
Selective reporting (reporting bias) | Low risk | All outcomes from Methods section reported in Results section |
Size | High risk | Fewer than 50 participants per arm of the study (25 propacetamol, 25 parecoxib) |